Table 2.
Feasibility data and method of measurement
| Feasibility outcome | Measurement | Progression criteria to phase II pilot RCT |
|---|---|---|
| Recruitment | Quantitative data | |
| Percentage of people with dementia invited into the study/number of people with dementia in total identified by health professionals | No criteria set | |
| Number of health professionals required to assist with recruitment into the study | No criteria set | |
| The time taken (up to 6 months) to recruit up to 50 dyads | No criteria set | |
| Number of dyads enrolled into the study per week | 2 dyads per week | |
| Percentage of dyads willing to undergo screening/number invited (calculated for GP, PCPD and memory service recruitment) | ≥15 % | |
| Percentage of dyads overall meeting the inclusion criteria/number invited | ≥5 % | |
| Percentage of dyads overall enrolled in the study/number invited | ≥5 % | |
| Qualitative data | ||
| Reasons for exclusion reported to the research team during health professional screening (GP, PCPDs, memory service) | No criteria set | |
| Reasons for ineligibility | No criteria set | |
| Identified barriers to recruitment (reasons for refusal of participation) | No criteria set | |
| Attrition | Quantitative data | |
| Percentage of dyads completing post-treatment (3 month) outcome measures | ≥70 % | |
| Reasons for dropout | No criteria set | |
| Qualitative data | ||
| Acceptability interviews with non-attendees and poor attendees (informal carers and people with dementia) | No criteria set | |
| Data collection procedures | Quantitative data | |
| Time taken and number of sessions to administer the screening measures | ≤2 h; ≤2 sessions | |
| Time taken and number of sessions to administer the baseline assessment | ≤2 h; ≤2 sessions | |
| Time taken and number of sessions to administer the follow-up assessments | ≤2 h; ≤2 sessions | |
| Percentage of missing items per questionnaire | ≤10 % | |
| Qualitative data | ||
| Acceptability interviews with participants concerning acceptability of research procedures | No criteria set | |
| Acceptability interviews with PWPs concerning acceptability and feasibility of research procedures | No criteria set | |
| Clinician adherence | Adherence to support protocol as determined by therapy tapes | ≥70 % |
| Clinical delivery | Quantitative data | |
| Time between being allocated to PWP and PWP undertaking the assessment session. | ≤2 weeks | |
| Session lengths | No criteria set | |
| Number of sessions received per dyad | No criteria set | |
| Settings of sessions (e.g., BeMe, community, home) | No criteria set | |
| Number of missed appointments | No criteria set | |
| Number of missed outcome measurement items | No criteria set | |
| PWP attrition | No criteria set | |
| Impact of severity of dementia (MMSE score) informing who can engage in the intervention | No criteria set | |
| Qualitative data | ||
| Acceptability interviews with participants | No criteria set | |
| Acceptability interviews with PWPs | No criteria set | |